Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience (Thyroid FNAC)

September 23, 2022 updated by: Mohamed Ahmed Orabi, Qena Oncology Center
Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.[2,3] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.[4] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid [5].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules [2,3]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm [2]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious [3].

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Qinā, Egypt, +2
        • Qena Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Thyroid diseases
  • Multi nodullar
  • single nodules
  • diffuse goiter
  • Thyroid diseases underwent FNAC Then Thyroid surgery

Exclusion Criteria:

  • Patients with no diagnostic FNAC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FNAC
Procedure: Fine Needle Aspiration Cytology
Comparison between FNAC and post operative specimen after thyroid surgery
Other Names:
  • Thyrodectomy
Experimental: post operative hitopathology
Procedure: Fine Needle Aspiration Cytology
Comparison between FNAC and post operative specimen after thyroid surgery
Other Names:
  • Thyrodectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of true positive results of FNAC after thyroidectomy
Time Frame: 10 days
Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience
10 days
Percentage of malignant thyroid nodules not observed by FNAC
Time Frame: 10 days
type of thyroid malignancy not observed by FNAC
10 days
Incidence of false negative results by FNAC
Time Frame: 10 days
false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion
10 days
Percentage of Total number of true results of FNAC to the total number of cases
Time Frame: 10 days
accuracy of FNAC
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qena Oncology Center

Investigators

  • Study Director: Amr M Makky, specialist surgical onclogy, Qena Oncology Center- Medical Military Academy
  • Principal Investigator: Mohamed Ahmed Orabi, specialist surgical onclogy, Qena Oncology Center
  • Study Chair: Mina Romany Tawfeek, Qena Oncology Center
  • Study Director: Mahmoud Ahmed Dosoky, specialist pathology, Qena Oncology Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

August 20, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qena Oncology Center 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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